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New treatment option for Endometrial Cancer
Official title Pipelle® Under Ultrasound Guidance (PUG) to Investigate Post-menopausal Bleeding.
ClinicalTrials.gov ID: NCT06501846
What this study is testing
- What it's testing
- TITLE Pipelle® under Ultrasound Guidance (PUG) to investigate post-menopausal bleeding: Randomised Controlled Trial BACKGROUND Women who are suspected of having endometrial cancer (cancer of the inner lining of the womb) due to vaginal bleeding after the menopause must have a tissue sample taken from this area to determine whether there is an abnormality. One method of doing this is by using a small biopsy device (such as a Pipelle®) in the outpatient setting.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- All patients with post-menopausal bleeding who require an endometrial biopsy. Further details:
- Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous...
- There is no upper age limit, however all patients must be 18 or above. Strict ultrasound criteria will be followed:
- Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of...
- Smooth, homogenous endometrium with a clearly defined border.
You likely can't join if
- Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural...
- Suspicion of non-benign myometrial pathology.
- History of endometrial cancer or endometrial hyperplasia.
- History of cervical cancer.
- Virgo intacta.
- Inability to tolerate vaginal examination.
See the full eligibility criteria
- All patients with post-menopausal bleeding who require an endometrial biopsy. Further details:
- Post-menopausal bleeding is defined as bleeding one year after a woman's last menstrual period or bleeding six months after starting continuous combined hormone replacement therapy.
- There is no upper age limit, however all patients must be 18 or above. Strict ultrasound criteria will be followed:
- Endometrium ≥5mm: this is the current cut off used by Imperial College Healthcare NHS Trust for a biopsy to be indicated in the context of post-menopausal bleeding.
- Smooth, homogenous endometrium with a clearly defined border.
- Focal endometrial pathology (including but not limited to endometrial polyps, type 0-2 fibroids, uterine septa and other uterine structural abnormalities).
- Suspicion of non-benign myometrial pathology.
- History of endometrial cancer or endometrial hyperplasia.
- History of cervical cancer.
- Virgo intacta.
- Inability to tolerate vaginal examination.
- Inability to consent.
- The denial or withdrawal of informed written consent.
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.